Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis

Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis - BETA-MG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000895-40-DK

Enrollment

Registered

2019-02-26

Start date

2019-03-28

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Salbutamol WZF 4 mg Pharmaceutical Form: Capsule INN or Proposed INN: Salbutamol Other descriptive name: SALBUTAMOL SULFATE PH. EUR. Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Generalized myasthenia gravis, stable dose of antimyasthenic medications, residual symptoms (MG-QOL15 > 10), age > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Malignant disease, worsening of symptoms due to concomitant diseases/medications, pregnancy/breast feeding, ischemic heart disease/cardiac arrhytmia/uncontrolled hypertension/uncontrolled diabetes

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy and tolerability of oral Salbutamol as adjuvant therapy in patients with generalized myasthenia gravis on stable medications with residual symptoms.;Secondary Objective: Not applicable;Primary end point(s): Change in MG-QOL15 score;Timepoint(s) of evaluation of this end point: Visit 4 vs. visit 2 (treatment period 1). Visit 7 vs. visit 5 (treatment period 2)	—

Measure

Time frame

Main Objective: To investigate the efficacy and tolerability of oral Salbutamol as adjuvant therapy in patients with generalized myasthenia gravis on stable medications with residual symptoms.;Secondary Objective: Not applicable;Primary end point(s): Change in MG-QOL15 score;Timepoint(s) of evaluation of this end point: Visit 4 vs. visit 2 (treatment period 1). Visit 7 vs. visit 5 (treatment period 2)

—

Secondary

Measure	Time frame
Secondary end point(s): Change in MG-ADL, QMG, MG-Composite, Neuro-QOL, ;Timepoint(s) of evaluation of this end point: Visit 4 vs. visit 2 (treatment period 1). Visit 7 vs. visit 5 (treatment period 2)	—

Countries

Denmark

Contacts

Public ContactJan L. S. Thomsen

Aarhus University Hospital

jathms@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026